Urinary albumin strip assay as a screening test to replace quantitative technology in certain conditions
-
Maria Salinas
, Maite López-Garrigós
Abstract
Background
The clinical laboratory plays a crucial role in the diagnosis and monitoring of chronic kidney disease. The quantitative measurement of urine albumin in a spot sample, expressed as ratio per creatinine (ACR) is the most frequently used biomarker for such a purpose. Our aim was to evaluate the diagnostic performances of a strip for measuring ACR for differentiating patients who are candidates for subsequent albumin quantification, and to evaluate the economic effects of its implementation.
Methods
We systematically measured strip analysis when quantitative urinary albumin was requested. Semiquantitative urinary albumin was measured using a UC-3500 (Sysmex, Kobe, Japan), based on the protein error of a pH indicator. We collected and reviewed all the values of quantified urinary albumin and their corresponding results in ACR strip tests. We calculated the diagnostic indicators for ACR at different albumin and creatinine values using the quantitative ACR measurement as a “gold standard”. We also studied the economic effects based on both tests prices (€1.31 for quantitative albumin plus creatinine, and €0.04 for an albumin strip).
Results
The study included 9148 patients (mean age 63, 46.3% men). The results at different albumin and creatinine cutoffs showed the best performance when 10 mg/L and above 50 mg/dL, respectively. Based on our results, we would have saved 3506 urine albumin and creatinine tests in the study period, corresponding to €4226.94.
Conclusions
The present study supports the use of the ACR strip test to identify pathological albuminuria values to be measured through quantitative methods. Considerable economic savings are possible.
Acknowledgments
Members of the PRIMLAB working group are the following: Beatriz Massa-Dominguez (Chief Executive); Antonio Gómez-Gras (Primary Care Director); Norma Iranzo (Medical vice-director); Alejandro Canals-Baeza (CS Santa Faz-Ayuntamiento); Jose L. López-Blasco (CS Hospital Provincial-Plá); Esperanza Gonzalez-Alvaro (CS Juan XXIII); Ramon de Juan Francés (CS Cabo Huertas); Jordi Gisbert-Segura (CS Campello); Rosario Oliver-Ros (CS Xixona); Alberto Asencio-Aznar (CS Mutxamel); Juan J. Ballester-Baixaulí (CS Sant Joan) and Carmen Pardo-Tomas (CSI Gerona).
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
1. James MT, Hemmelgarn BR, Tonelli M. Early recognition and prevention of chronic kidney disease. Lancet 2010;375: 1296–309.10.1016/S0140-6736(09)62004-3Search in Google Scholar
2. Chapter 1: Definition and classification of CKD. Kidney Int Suppl 2013;3:19–62.10.1038/kisup.2012.64Search in Google Scholar PubMed PubMed Central
3. Park JI, Baek H, Kim BR, Jung HH. Comparison of urine dipstick and albumin:creatinine ratio for chronic kidney disease screening: a population-based study. PLoS One 2017;12:e0171106.10.1371/journal.pone.0171106Search in Google Scholar PubMed PubMed Central
4. Of OJOS, Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl 2013;3:4–4.Search in Google Scholar
5. Mills KT, Xu Y, Zhang W, Bundy JD, Chen C-S, Kelly TN, et al. A systematic analysis of worldwide population-based data on the global burden of chronic kidney disease in 2010. Kidney Int 2015;88:950–7.10.1038/ki.2015.230Search in Google Scholar PubMed PubMed Central
6. Weir MR. Microalbuminuria and cardiovascular disease. Clin J Am Soc Nephrol 2007;2:581–90.10.2215/CJN.03190906Search in Google Scholar PubMed
7. Sung K-C, Ryu S, Lee J-Y, Lee SH, Cheong E, Hyun Y-Y, et al. Urine albumin/creatinine ratio below 30 mg/g is a predictor of incident hypertension and cardiovascular mortality. J Am Heart Assoc 2016;5:e003245.10.1161/JAHA.116.003245Search in Google Scholar PubMed PubMed Central
8. Salinas M, López-Garrigós M, Flores E, Leiva-Salinas M, Esteban P, Ahumada M, et al. Indications for laboratory tests in primary care: assessment of the most frequent indications and requests with blank clinical information. Biochem Med 2016;26:431–5.10.11613/BM.2016.045Search in Google Scholar PubMed PubMed Central
9. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2016;39:S1–106.Search in Google Scholar
10. Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Böhm M, et al. 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 2013;34:2159–219.10.1201/b17072-61Search in Google Scholar
11. Salinas M, Lopez-Garrigos M, Flores E, Leiva-Salinas C, Pilot Group of the Appropriate Utilization of Laboratory Tests. ANNALS EXPRESS: Urinary albumin: a risk marker under-requested in primary care in Spain. Ann Clin Biochem 2018;55:281–6.10.1177/0004563217716475Search in Google Scholar PubMed
12. Martin H. Laboratory measurement of urine albumin and urine total protein in screening for proteinuria in chronic kidney disease. Clin Biochem Rev 2011;32:97–102.Search in Google Scholar
13. Gerstein HC, Mann JF, Yi Q, Zinman B, Dinneen SF, Hoogwerf B, et al. Albuminuria and risk of cardiovascular events, death, and heart failure in diabetic and nondiabetic individuals. J Am Med Assoc 2001;286:421–6.10.1001/jama.286.4.421Search in Google Scholar PubMed
14. Levin A, Stevens PE. Summary of KDIGO 2012 CKD Guideline: behind the scenes, need for guidance, and a framework for moving forward. Kidney Int 2014;85:49–61.10.1038/ki.2013.444Search in Google Scholar PubMed
15. Chronic kidney disease in adults: assessment and management|Guidance and guidelines|NICE. NICE.Search in Google Scholar
16. Hemmelgarn BR, Manns BJ, Lloyd A, James MT, Klarenbach S, Quinn RR, et al. Relation between kidney function, proteinuria, and adverse outcomes. J Am Med Assoc 2010;303:423.10.1001/jama.2010.39Search in Google Scholar PubMed
17. Konta T, Hao Z, Takasaki S, Abiko H, Ishikawa M, Takahashi T, et al. Clinical utility of trace proteinuria for microalbuminuria screening in the general population. Clin Exp Nephrol 2007;11:51–5.10.1007/s10157-006-0458-zSearch in Google Scholar PubMed
18. White SL, Yu R, Craig JC, Polkinghorne KR, Atkins RC, Chadban SJ. Diagnostic accuracy of urine dipsticks for detection of albuminuria in the general community. Am J Kidney Dis 2011;58:19–28.10.1053/j.ajkd.2010.12.026Search in Google Scholar PubMed
19. Nagrebetsky A, Jin J, Stevens R, James T, Adler A, Park P, et al. Diagnostic accuracy of urine dipstick testing in screening for microalbuminuria in type 2 diabetes: a cohort study in primary care. Fam Pract 2013;30:142–52.10.1093/fampra/cms057Search in Google Scholar PubMed
20. Tugirimana PL, Delanghe JR. Development of an affordable dye-stained microalbuminuria screening test. Nephrol Dial Transplant 2009;24:1485–90.10.1093/ndt/gfn705Search in Google Scholar PubMed
21. Delanghe JR, Himpe J, De Cock N, Delanghe S, De Herde K, Stove V, et al. Sensitive albuminuria analysis using dye-binding based test strips. Clin Chim Acta 2017;471:107–12.10.1016/j.cca.2017.05.032Search in Google Scholar PubMed
22. Graziani MS, Gambaro G, Mantovani L, Sorio A, Yabarek T, Abaterusso C, et al. Diagnostic accuracy of a reagent strip for assessing urinary albumin excretion in the general population. Nephrol Dial Transplant 2009;24:1490–4.10.1093/ndt/gfn639Search in Google Scholar PubMed
23. Cho M-C, Ji M, Kim SY, Choe W, Lee W, Chun S, et al. Evaluation of the URiSCAN super cassette ACR semiquantitative urine dipstick for microalbuminuria screening. J Clin Lab Anal 2014;28:281–6.10.1002/jcla.21681Search in Google Scholar PubMed PubMed Central
24. Manns B, Hemmelgarn B, Tonelli M, Au F, Chiasson TC, Dong J, et al. Population based screening for chronic kidney disease: cost effectiveness study. Br Med J 2010;341:c5869.10.1136/bmj.c5869Search in Google Scholar PubMed PubMed Central
25. Salinas M, López-Garrigós M, Flores E, Uris J, Leiva-Salinas C. Larger differences in utilization of rarely requested tests in primary care in Spain. Biochem Med 2015;25:410–5.10.11613/BM.2015.041Search in Google Scholar PubMed PubMed Central
©2019 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Obituary
- Jillian Russyll (AKA Jill) Tate
- Editorial
- The long way to standardization of practices: HbA1c as archetypal example
- Reviews
- Secretory tumors of the pituitary gland: a clinical biochemistry perspective
- Thalassemia in the laboratory: pearls, pitfalls, and promises
- Opinion Paper
- Diagnostic biomarkers of muscle injury and exertional rhabdomyolysis
- General Clinical Chemistry and Laboratory Medicine
- Patient’s knowledge and awareness about the effect of the over-the-counter (OTC) drugs and dietary supplements on laboratory test results: a survey in 18 European countries
- National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017
- Urinary albumin strip assay as a screening test to replace quantitative technology in certain conditions
- Cerebrospinal fluid free kappa light chains and kappa index perform equal to oligoclonal bands in the diagnosis of multiple sclerosis
- Different immunoreactivity of monomers and dimers makes automated free light chains assays not equivalent
- The utility of saliva testing in the estimation of uremic toxin levels in serum
- Determination of cannabinoids in oral fluid and urine of “light cannabis” consumers: a pilot study
- Moving from the second to the third generation Roche PTH assays: what are the consequences for clinical practice?
- Baseline hepcidin measurement in the differential diagnosis of anaemia for elderly patients and its correlation with the increment of transferrin saturation following an oral iron absorption test
- Reference Values and Biological Variations
- A multicenter study for the evaluation of the reference interval for TSH in Italy (ELAS TSH Italian Study)
- Cancer Diagnostics
- Urinary measurement of circulating tumor DNA for treatment monitoring and prognosis of metastatic colorectal cancer patients
- BCL2L12: a multiply spliced gene with independent prognostic significance in breast cancer
- Diabetes
- The global impact of the International Federation of Clinical Chemistry and Laboratory Medicine, Education and Management Division: engaging stakeholders and assessing HbA1c quality in a multicentre study across China
- The frequency of testing for glycated haemoglobin, HbA1c, is linked to the probability of achieving target levels in patients with suboptimally controlled diabetes mellitus
- Letters to the Editor
- Response to article by Caponi et al. about serum free light chains
- Response to Letter to the Editor about immunochemical measurement of urine free light chains
- Estimated GFR-specific 99th percentiles for high-sensitive cardiac troponin T based on the adjusted analytical change limit (adjACL) in hospitalized patients
- Perioperative heart-type fatty acid binding protein concentration cutoffs for the identification of severe acute kidney injury in patients undergoing cardiac surgery
- A peculiar reaction curve with dual spikes in absorbance during a total bilirubin assay in spite of accurate results induced by high M-protein concentration
- Extremely low high-density-lipoprotein cholesterol due to an unusual non-inherited cause: a case report
- A single-center performance evaluation of the fully automated iFlash anti-Müllerian hormone immunoassay
- Genetic polymorphisms and variants in the LDL receptor associated with familial hypercholesterolemia: cascade screening and identification of the variants 666C>A, 862G>A, 901G>A, and 919G>A of a Brazilian family
- Undetected paraganglioma by functional imaging techniques: case report
- A particular case of AML patient with the polymorphism G105G (rs11554137) and the missense mutation R132C in IDH1 gene
- Atypical “hairy cell-like” presentation of leukemic mantle cell lymphoma
- Evaluation of a rapid centrifugation step (4500 g for 2 min) in coagulation assays to monitor direct oral anticoagulants
Articles in the same Issue
- Frontmatter
- Obituary
- Jillian Russyll (AKA Jill) Tate
- Editorial
- The long way to standardization of practices: HbA1c as archetypal example
- Reviews
- Secretory tumors of the pituitary gland: a clinical biochemistry perspective
- Thalassemia in the laboratory: pearls, pitfalls, and promises
- Opinion Paper
- Diagnostic biomarkers of muscle injury and exertional rhabdomyolysis
- General Clinical Chemistry and Laboratory Medicine
- Patient’s knowledge and awareness about the effect of the over-the-counter (OTC) drugs and dietary supplements on laboratory test results: a survey in 18 European countries
- National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017
- Urinary albumin strip assay as a screening test to replace quantitative technology in certain conditions
- Cerebrospinal fluid free kappa light chains and kappa index perform equal to oligoclonal bands in the diagnosis of multiple sclerosis
- Different immunoreactivity of monomers and dimers makes automated free light chains assays not equivalent
- The utility of saliva testing in the estimation of uremic toxin levels in serum
- Determination of cannabinoids in oral fluid and urine of “light cannabis” consumers: a pilot study
- Moving from the second to the third generation Roche PTH assays: what are the consequences for clinical practice?
- Baseline hepcidin measurement in the differential diagnosis of anaemia for elderly patients and its correlation with the increment of transferrin saturation following an oral iron absorption test
- Reference Values and Biological Variations
- A multicenter study for the evaluation of the reference interval for TSH in Italy (ELAS TSH Italian Study)
- Cancer Diagnostics
- Urinary measurement of circulating tumor DNA for treatment monitoring and prognosis of metastatic colorectal cancer patients
- BCL2L12: a multiply spliced gene with independent prognostic significance in breast cancer
- Diabetes
- The global impact of the International Federation of Clinical Chemistry and Laboratory Medicine, Education and Management Division: engaging stakeholders and assessing HbA1c quality in a multicentre study across China
- The frequency of testing for glycated haemoglobin, HbA1c, is linked to the probability of achieving target levels in patients with suboptimally controlled diabetes mellitus
- Letters to the Editor
- Response to article by Caponi et al. about serum free light chains
- Response to Letter to the Editor about immunochemical measurement of urine free light chains
- Estimated GFR-specific 99th percentiles for high-sensitive cardiac troponin T based on the adjusted analytical change limit (adjACL) in hospitalized patients
- Perioperative heart-type fatty acid binding protein concentration cutoffs for the identification of severe acute kidney injury in patients undergoing cardiac surgery
- A peculiar reaction curve with dual spikes in absorbance during a total bilirubin assay in spite of accurate results induced by high M-protein concentration
- Extremely low high-density-lipoprotein cholesterol due to an unusual non-inherited cause: a case report
- A single-center performance evaluation of the fully automated iFlash anti-Müllerian hormone immunoassay
- Genetic polymorphisms and variants in the LDL receptor associated with familial hypercholesterolemia: cascade screening and identification of the variants 666C>A, 862G>A, 901G>A, and 919G>A of a Brazilian family
- Undetected paraganglioma by functional imaging techniques: case report
- A particular case of AML patient with the polymorphism G105G (rs11554137) and the missense mutation R132C in IDH1 gene
- Atypical “hairy cell-like” presentation of leukemic mantle cell lymphoma
- Evaluation of a rapid centrifugation step (4500 g for 2 min) in coagulation assays to monitor direct oral anticoagulants